IPS CaseDesigner
K-Number: K161634 · 2016-11-10
ApplicantNobel Biocare AB
Decision Date2016-11-10
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
IPS CaseDesigner is a medical device manufactured by Nobel Biocare AB. It received FDA 510(k) clearance on 2016-11-10 under approval number K161634. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the IPS CaseDesigner?
IPS CaseDesigner is a medical device that received FDA 510(k) clearance on 2016-11-10. It is manufactured by Nobel Biocare AB. The 510(k) number is K161634.
When was IPS CaseDesigner approved by the FDA?
IPS CaseDesigner received FDA 510(k) clearance on 2016-11-10, under approval number K161634.
What company makes IPS CaseDesigner?
IPS CaseDesigner is manufactured by Nobel Biocare AB.
What is the FDA product code for IPS CaseDesigner?
The FDA product code for IPS CaseDesigner is LLZ.
Other Devices by Nobel Biocare AB
Related Devices (Code: LLZ)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.